ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20564

Study information

Scientific title

Use of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) – a feasibility study in non­melanoma skin cancers

Acronym

Study hypothesis

The aim of this study is to explore the practicality and value of the Skin Cancer Quality of Life Impact Tool (SCQOLIT) for non-melanoma skin cancer (NMSC) to patients and clinicians in the dermatology clinical setting.

Ethics approval

Oxford B Research Ethics Committee, 18/06/2015, ref: 14/SC/1446

Study design

Prospective non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intervention

Three hundred patients (100 with squamous cell carcinoma, 200 with basal cell carcinoma) identified in Dermatology outpatient clinics will be recruited to complete SCQOLIT questionnaires at baseline (after histological confirmation of NMSC), at 3 months (by postal or face:face) and at 6-9 months (high risk patients only). Structured interviews with twenty patients and focus group work with 10-15 Dermatology staff will establish acceptability of the SCQOLIT and identify any barriers to implementation. Both quantitative and qualitative analyses will be undertaken.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Acceptability of SCQOLIT tool as determined by analysis of patients participation rates and qualitative analysis of patient and staff preferences at the end of the study.

Secondary outcome measures

Overall trial start date

01/07/2015

Overall trial end date

30/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or above2. Participant is willing and able to give informed consent for participation in the study.3. All patients with a histopathological diagnosis of NMSC (primary or recurrent disease)4. All treatments used for NMSC will be included in the study; excision, shave excision, curettage and cautery, Mohs micrographic surgery, photodynamic therapy and topical treatments e.g. imiquimod cream

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. Concurrent internal malignancy as this is likely to significantly influence quality of life (QOL)2. Patients referred on to other specialties for management of their skin cancer e.g. Plastic surgeons / Clinical oncology3. Other significant dermatological diseases e.g. severe inflammatory or blistering skin conditions as this may influence QOL4. Inability to consent for themselves